21 results · 24ms · Sources: EU EUDAMED, US FDA

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Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y

FDA 510(k)
FDA Class 2 ·Cardiovascular

BD MAX¿ ENTERIC BACTERIAL PANEL

FDA Adverse Event
Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCI·December 6, 2023

VALVED TEARAWAY INTRODUCER GENERATION II

FDA 510(k)
FDA Class 2 ·Cardiovascular

MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK)

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

BD MAX¿ ENTERIC BACTERIAL PANEL

FDA Adverse Event
Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCI·December 6, 2023

CODA BALLOON CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code DQY·April 4, 2019

OPTIPAC 60 REFOB BONE CMT R-3

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code LOD·May 11, 2026

OBTRYX SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 17, 2013

ACCESS® 2 IMMUNOASSAY SYSTEM

FDA Adverse Event
Injury ·BECKMAN COULTER, INC.·Product code MMI·July 22, 2011

MOBILE INFANT WARMER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code FMT·September 19, 2008

BIOMET BONE CMENT R 1X40 JP

FDA Adverse Event
Malfunction ·BIOMET FRANCE S.A.R.L.·Product code LOD·May 22, 2025

REFOBACIN BONE CEMENT R 1X40-3

FDA Adverse Event
Malfunction ·BIOMET FRANCE S.A.R.L.·Product code LOD·June 18, 2025

OPTIPAC 80 BIOMET BC R

FDA Adverse Event
Death ·BIOMET FRANCE S.A.R.L.·Product code LOD·April 9, 2026

BIOMET BONE CEMENT R 40 -3

FDA Adverse Event
Malfunction ·BIOMET FRANCE S.A.R.L.·Product code LOD·July 31, 2025

BIOMET BONE CMENT R 1X40 JP

FDA Adverse Event
Malfunction ·BIOMET FRANCE S.A.R.L.·Product code LOD·June 17, 2025

OPTIPAC 60 REFOB BONE CMT R-3

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code LOD·February 5, 2025

OPTIPAC 60 REFOB BONE CMT R-3

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code LOD·February 5, 2025

BIOMET BONE CMENT R 1X40 JP

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code LOD·October 8, 2025

BIOMET BONE CMENT R 1X40 JP

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code LOD·October 8, 2025

BIOMET BONE CMENT R 1X40 JP

FDA Adverse Event
Malfunction ·BIOMET FRANCE S.A.R.L.·Product code LOD·April 8, 2025